BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZEISS 30 SL-OMNI

    MDR report key: 58976 · Received December 27, 1996

    Report

    Report Number
    2914019-1996-00014
    Event Type
    Other
    Date Received
    December 27, 1996
    Date of Event
    September 17, 1996
    Report Date
    December 26, 1996
    Manufacturer
    COHERENT MEDICAL LASER GRP.
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR EXPERIENCED A FLASHBACK FROM THE LASERLINK WHEN USING THE DEVICE WAVELENGTH. HE HAD VISION PROBLEMS FOR 10 DAYS AFTER THE INCIDENT, WHICH WAS SINCE GONE AWAY. DR STATED THAT THEY KNEW THAT THE FILTER GLASS WAS NOT FILTERING THE RED WAVELENGTH. DR ALSO STATED THAT HE DID NOT KNOW IF PHOTOTOXICITY OF HIS MACULA WILL BE A FUTURE PROBLEM. THE LASERLINK FOR THE DEVICE (MULTIPLE WAVELENGTH LASER) HAD THE INCORRECT FILTER GLASS INSTALLED BY MFG. IT DID NOT BLOCK THE RED WAVELENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEISS 30 SL-OMNI OPHTHALMIC DELIVERY SYS HQF COHERENT MEDICAL LASER GRP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other